EcoFit cup cementless: Risk of loose plugs during bone impact
EcoFit cup cementless implants with model numbers 02200046-02200068 may have loose plugs during bone impact, potentially requiring revision surgery. Affected units include specific sizes and lot numbers.
Use caution until it’s fixed
A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.
Contact the company
What happened, in plain English
IMPLANTCAST recalls certain EcoFit cup cementless hip implants due to a risk that plugs may become loose during bone impact, which could extend surgery time or require revision surgery. The hazard is linked to the patient's bone quality, such as osteosclerosis. Read more at govinfonow.com/recall/62583-ecofit-cup-cementless-risk-of-loose-plugs-during-bone-impact.
Source Summary by GovInfoNow · govinfonow.com/recall/62583-ecofit-cup-cementless-risk-of-loose-plugs-during-bone-impact · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2050-2021
Cite this page
“EcoFit cup cementless: Risk of loose plugs during bone impact.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62583-ecofit-cup-cementless-risk-of-loose-plugs-during-bone-impact. Based on FDA recall #Z-2050-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2050-2021%22&limit=1).
Why it’s dangerous
During hip replacement surgery, the acetabular cup is impacted into the bone. If the bone quality is osteosclerotic (dense), the plugs in the cup may become loose, potentially extending surgery time or requiring a revision operation.
Who’s affected
Orthopedic surgeons and patients who have received the recalled EcoFit cup cementless implants (models 02200046-02200068) are most at risk. Patients with osteosclerotic bone are particularly vulnerable.
How to tell if you have this one
Check for model numbers 02200046 through 02200068 on the implant packaging or label. Lot numbers listed in the recall include specific sequences like 1736252001, 17420NM001, and others. The UDI (Unique Device Identifier) starts with 04048844005368 for the smallest model.
- Brand
IMPLANTCAST- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number (02200046-02200068) and lot numbers listed in the recall to confirm if your implant is affected.
Contact Manufacturer
Reach out to IMPLANTCAST GMBH for further assistance or to confirm if your specific implant is part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “U.S. Nationwide distribution in the states of FL and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Texas.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2050-2021 (May 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2050-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.